DermACELL in Subjects With Chronic Wounds of the Lower Extremities

NACompletedINTERVENTIONAL
Enrollment

202

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

January 31, 2016

Study Completion Date

April 30, 2016

Conditions
Diabetic Foot Ulcer
Interventions
OTHER

DermACELL

Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).

OTHER

GraftJacket

Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).

OTHER

Conventional Care Dressings

"Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:~* If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.~* Hydrogels can also be used if the wound is in need of moisture.~* For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.~A secondary dressing may be desired to add either loft or cushion."

Trial Locations (12)

15240

VA Pittsburgh Healthcare System, Pittsburgh

18512

Wound Institute and Reseach Center, Dunmore

32561

Andrews Research and Education Institute, Gulf Breeze

36111

Institute for Advanced Wound Care, Montgomery

60064

Rosalind Franklin University, CLEAR, North Chicago

85723

Southern Arizona VA Health Care System, Tucson

92009

ILD Research Center, Carlsbad

93720

Limb Preservation Platform, Fresno

93721

Limb Preservation Platform, Fresno

94546

Center for Clinical Research, Castro Valley

06851

Fairfield County Foot Surgeons, Norwalk

02118

Boston Medical College, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

LifeNet Health

INDUSTRY

NCT01970163 - DermACELL in Subjects With Chronic Wounds of the Lower Extremities | Biotech Hunter | Biotech Hunter